Ensuring compliance with applicable regulatory requirements is a critical component of any healthcare transaction. The laws and regulations that govern and restrict transactions in the healthcare industry are numerous and can often be complex. Even relatively simple agreements may lead to a host of potential regulatory obstacles. Additionally, agreements that are commonplace and benign in other industries may expose parties to significant civil or criminal liability if they are utilized in the healthcare field.
At Elliott Sauter, PLLC, we understand how vital complying with regulatory framework is for healthcare providers. It is far more beneficial to address potential regulatory issues at the beginning of a relationship rather than waiting for those issues to manifest themselves as civil or criminal regulatory problems.
We assist our clients in assessing and complying with their obligations under state and federal law while simultaneously allowing them to achieve their business objectives. Our advice comes from years of experience in aiding clients with healthcare matters as well as from our time in the United States Department of Justice (DOJ) prosecuting crimes in the healthcare industry. We have analyzed hundreds of healthcare organizational structures from both a criminal and civil perspective, and we have observed critical structural decisions that can mean the difference between success and failure.
Stark Law, Anti-Kickback Statute, and State Law
Financial relationships between ancillary service providers and referring physicians present one of the most common and potentially dangerous regulatory risks to stakeholders in the healthcare industry. Whether these relationships arise through physician ownership or management contracts, medical directorships, lease arrangements, or through contracts for personal services, these proposed arrangements should be carefully scrutinized for their likelihood to develop improper incentives. Agreements should be carefully crafted to ensure compliance with one or more safe harbors to the Anti-Kickback Statute (AKS) and with applicable exceptions to the Ethics in Patient Referrals Act (Stark).
We assist healthcare companies with physician ownership by evaluating their ownership structures for compliance with federal law, including AKS safe harbor protection. Where necessary, we also advise clients on the processes needed to adjust ownership or business practices to achieve and maintain compliance. We additionally identify risk areas along with steps to mitigate that risk.
We help clients negotiate and maintain management contracts that do not run afoul of the AKS or Stark. These agreements are often supported by fair market valuations and have carefully scheduled compensation. When management companies have physician ownership or physician relationships, we monitor and evaluate those relationships as well. We also help our clients understand the critical differences between management and marketing relationships.
Medical directorships are one type of agreement that is frequently the subject of government regulatory enforcement activities. We further assist clients in understanding their limitations in contracting for the services of medical directors. We frequently recommend that clients obtain fair market valuation of the hourly and total compensation offered to medical directors, particularly if those medical directors also refer patients. Ensuring that documentation creation and retention accurately demonstrates the performance of appropriate services is another key feature of medical directorship compliance.
Lease or purchase agreements for space or equipment made in connection with referring providers need to be carefully tailored to avoid violating the AKS or Stark. Overvaluations or undervaluations of property purchased or leased from a referring physician can both serve as mechanisms of improper remuneration.
Personal Services and Other Agreements
The healthcare industry is constantly evolving and we, along with our clients, frequently encounter new agreements or models that incorporate referring physicians with the potential to affect referral patterns. We assist clients in evaluating these models and help reduce or eliminate their exposure to regulatory risk. We also assist clients in establishing the paperwork and institutions necessary for oversight of their employee and/or independent contractor marketing personnel who present another significant risk when it comes to potential financial relationships with referring physicians.